ew treatment regimens for treatment of Post Kala Azar Dermal Leishmaniasis patients in India and Bangladesh regio

Phase 2

Completed

• Conditions: Health Condition 1: null- Post Kala Azar Dermal Leishmaniasis

• Registration Number: CTRI/2017/04/008421
• Lead Sponsor: Drugs for Neglected Diseases initiative DNDi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-04-30
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 96

Inclusion Criteria

1. Confirmed PKDL case by clinical presentation and demonstration of parasites by microscopy in a skin smear or biopsy or by qPCR, with stable or progressive disease for at least 4 months

2. Male or Female patients aged 6 to 60 years

3. Written voluntarily informed consent from adult patient and from parent / guardian in case of children <18 years old. In the case of minors, assent from the children will also be obtained according to country regulations.

Exclusion Criteria

1. Patients who had prior treatment of PKDL within last 2 years.

2. Pregnant and lactating women and women of childbearing age (12 to 55 years) who, before randomization, cannot be assured contraceptive cover during treatment and 5 months thereafter

3. Patients with sign and symptoms of severe diseases: defined as suffering from a concomitant severe infection such as TB or any other serious known underlying disease (cardiac, renal, hepatic)

4. Severe malnutrition defined by BMI for age WHO reference curves for gender, Z score < -3 for subjects 6 - 19 years; BMI < 16 for subjects > 19-years old

5. Patients with haemoglobin < 5g/dL

6. Patients with abnormal liver function (ALT and AST) tests of more than three times the normal range.

7. Patients with total bilirubin levels >1.5 times the upper normal range

8. Patients with serum creatinine above the upper normal range

9. Patients with serum potassium < 3.5 mmol/L

10. Patients with a positive HIV test as applicable

11. Patients / guardian not willing to participate

12. Patients with history of allergy or hypersensitivity to the relevant study drug

13. Patients on immunomodulators

Study & Design

• Study Type: Interventional
• Study Design: Not specified